510(k) K832423
- Device
- ENVISION G21 I/A ENPAK
- Applicant
- ENVISION, INC.
- 510(k) number
- K832423
- Product code
- HQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-12
- Date received
- 1983-07-22
- Regulation
- 886.4670
- Classification name
- Unit, Phacofragmentation
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code HQC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261264 | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ | Bausch and Lomb | 2026-05-15 |
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | 2026-03-25 |
| K250501 | System Sophi | This AG | 2025-11-14 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | 2024-07-26 |
| K233398 | Faros Surgical System | Oertli Instrumente AG | 2024-06-27 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | 2024-06-21 |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | 2024-02-26 |
| K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024-01-10 |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | 2023-07-31 |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | 2022-04-19 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases